Tobacco Chewing Gum Formulation

ABSTRACT

A chewing gum formulation including tobacco particles and a gum base, where the gum base includes one or more hydrophobic gum base polymers, and where the tobacco particles are made from tobacco leaves. The amount of tobacco particles is between 0.5 and 30% by weight of the chewing gum formulation, and nicotine is released from the tobacco particles when chewing the chewing gum formulation.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit, under 35 U.S.C. §119(e), ofU.S. Provisional Patent Application No. 61/499,041 filed on Jun. 20,2011, the content of which is incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to the field of chewing gum. In particularthe present invention relates to a tobacco chewing gum formulation.

BACKGROUND OF THE INVENTION

It is well known to use chewing gum comprising nicotine or complexes ofnicotine to provide a user with appropriate doses of nicotine.

Considerable effort has been put into formulating chewing gum that candeliver nicotine to a user in a way close to what is experienced by aperson when smoking a cigarette.

Different ways of incorporating the nicotine into the chewing gum bymixing or initial preparation of the nicotine have been disclosed in theprior art.

One of these prior art disclosures includes U.S. Pat. No. 5,488,962specifically dealing with the problem of simulating the cigarettesmoking with respect to the level of nicotine retention in the blood andsaliva. According to the disclosure, an initial peak of nicotine levelin the blood is obtained more similar to the corresponding absorption ofnicotine when smoking a cigarette. The levels reached after a certaintime corresponds to conventional nicotine-containing chewing gums.

A problem is, however, that the modification of the initial release maytypically result in a relatively low release after only a few minutes.

It is an object of the present invention to obtain a nicotine releasefrom chewing gum which, when compared to conventionally knownnicotine-containing chewing gums, exhibits a faster release of nicotineboth initially and within the first minutes of chewing; therebyproviding a release of nicotine from the chewing gum closer to therelease obtained when a user is smoking a cigarette.

SUMMARY OF THE INVENTION

The present invention relates to a chewing gum formulation comprisingtobacco particles and a gum base, wherein the gum base comprises one ormore hydrophobic gum base polymers, and wherein the tobacco particlesare made from tobacco leaves,

-   -   wherein the amount of tobacco particles is between 0.5 and 30%        by weight of the chewing gum formulation,    -   wherein nicotine is released from the tobacco particles when        chewing the chewing gum formulation.

It has surprisingly been found by the present inventor that substantialand effective amounts of nicotine are released from a chewing gumformulation comprising tobacco particles. Impressive rates of nicotinerelease from a chewing gum formulation comprising tobacco particles maybe achieved. As such this may be advantageous over conventional nicotinechewing gum when a fast release of nicotine is to be obtained.

In an embodiment of the invention, the tobacco particles comprisetobacco fibres and the tobacco fibres are retained in the gum base aftera 10 minute chewing process.

It should be noted that tobacco fibres generally comprise a significantamount of cellulose fibres.

Accordingly, impressive rates of nicotine release are obtained and atthe same time fibres of the tobacco particles are retained in the gumbase. It may be a benefit that tobacco fibres are retained in the gumbase, e.g. if the tobacco particles include harmful substances that maygive rise to disorders in the human body. Especially, harmful substancesthat may give rise to disorders in the human body may in this way beencapsulated in the gum base and excluded to enter the human body.

Unless otherwise stated, when tobacco fibres or compounds are mentionedto be retained in the gum base or released from a chewing gumformulation after a chewing process this chewing process refers to theprocedure set forth in the Ph. Eur. 6^(th) ed. 2.9.25, at pH=7.4, achewing rate of 60 chew per minute, and with the temperature of themedium at 37° C.

The measurement of the retained fibres or compounds may be establishedby measuring the amounts of retained tobacco fibres in the chewing gumafter chewing or measuring the amounts of released tobacco fibres,whichever method is most appropriate.

The measurement of the retained fibres or compounds may be establishedby measuring the amounts remaining in the chewing gum after chewing ormeasuring the amounts of released components, whichever method is mostappropriate.

Unless otherwise stated the retention of the tobacco particles in thegum base or the retention of the tobacco fibers from the tobacco in thegum base is measured as follows:

The chewing gum is chewed referring to the procedure set forth in thePh. Eur. 6^(th) ed. 2.9.25, at pH=7.4, a chewing rate of 60 chew perminute, and with the temperature of the medium at 37° C. for about 10minutes.

The buffer is filtered through weighed filter paper and the residue onthe filter paper is dried in an oven at about 50° C. until dry. Afterweighing the dried filter paper with residue and subtracting a blind(dried filter paper without residue), the result is taken as tobaccofibres from tobacco released from the chewing gum. This is then comparedto the amount of tobacco fibres in the chewing gum before chewing. Bysubtracting the measured released amount form the amount originallypresent and dividing by the amount originally present, the percentageretained may be calculated.

In an embodiment of the invention chewing gum formulation comprisestobacco particles and a gum base, wherein the gum base comprises one ormore hydrophobic gum base polymers, and wherein the tobacco particlesare made from tobacco leaves,

-   -   wherein the amount of tobacco particles is between 0.5 and 30%        by weight of the chewing gum formulation,    -   wherein nicotine is released from the tobacco particles when        chewing the chewing gum formulation, and    -   wherein at least 50% by weight, preferably at least 75% by        weight of the tobacco particles have a size between 50 and 2000        μm, preferably between 100 and 1200 μm, such as between 300 and        750 μm.

According to an advantageous embodiment of the present invention thetobacco particles may be obtained by finely dividing tobacco leaves. Tothe surprise of the inventors a pleasant texture of the chewing gum maybe obtained in this embodiment. In particular, it may be beneficial notto have too large particles in the chewing gum formulation. Such largeparticles may result in unpleasant chew characteristics. At the sametime, a too large amount of very small dimensions may result in a toolarge release of nicotine. The preferred rate of the release of nicotinefrom the chewing gum may be found within the selected tobacco particlesize range.

By the term “size” here is meant a measure of the maximum dimension ofthe tobacco particles.

In an embodiment of the invention a chewing gum formulation comprisestobacco particles and a gum base, wherein the gum base comprises one ormore hydrophobic gum base polymers, and wherein the tobacco particlesare made from tobacco leaves,

-   -   wherein the amount of tobacco particles is between 0.5 and 30%        by weight of the chewing gum formulation,    -   wherein nicotine is released from the tobacco particles when        chewing the chewing gum formulation, and    -   wherein the tobacco particles have a water content ranging from        2 to 40% by weight, preferably 5 to 30% by weight, such as 10 to        20% by weight.

The presence of water in the tobacco particles may affect both the easeof handling the tobacco particles in the production and also the initialsoftness of the chewing gum formulation. In addition the release rate ofnicotine may be improved by selection of a preferred range of watercontent of the tobacco particles.

It has surprisingly been found by the present inventor that a relativelybroad range of water content in the applied tobacco particles gives riseto chewing gum formulations with superior quality both with respect tonicotine release, taste and texture compared to nicotine-containingchewing gum of the prior art.

In an embodiment of the invention a chewing gum formulation comprisestobacco particles and a gum base, wherein the gum base comprises one ormore hydrophobic gum base polymers, and wherein the tobacco particlesare made from tobacco leaves,

-   -   wherein nicotine is released from the tobacco particles when        chewing the chewing gum formulation, and    -   wherein the amount of tobacco particles is between 3-25%, such        as 4-20%, or 5-15% by weight of the chewing gum formulation.

According to embodiments of the present invention, the amount of tobaccoparticles in the chewing gum formulation has a pronounced influence onthe taste, texture and nicotine release.

In an embodiment of the invention a chewing gum formulation comprisestobacco particles and a gum base, wherein the gum base comprises one ormore hydrophobic gum base polymers, and wherein the tobacco particlesare made from tobacco leaves,

-   -   wherein the amount of tobacco particles is between 0.5 and 30%        by weight of the chewing gum formulation,    -   wherein nicotine is released from the tobacco particles when        chewing the chewing gum formulation, and    -   wherein the amount of nicotine in the tobacco particles is        between 0.2-10%, preferably 0.4-8%, such as 0.6-6% or 0.8-4% by        weight of the tobacco particles.

The nicotine content of tobacco leaves may vary widely for differenttypes of tobacco. According to advantageous embodiments of the presentinvention, the amount of nicotine in the tobacco particles may be higherthan 0.2%. On the other hand, the amount of nicotine in the tobaccoparticles may, according to the aforementioned advantageous embodiments,be lower than 10% to better be able to mask the somewhat unpleasanttaste of nicotine, when a certain amount of tobacco particles isapplied.

In an embodiment of the invention a chewing gum formulation comprisestobacco particles and a gum base, wherein the gum base comprises one ormore hydrophobic gum base polymers, and wherein the tobacco particlesare made from tobacco leaves,

-   -   wherein the amount of tobacco particles is between 0.5 and 30%        by weight of the chewing gum formulation,    -   wherein nicotine is released from the tobacco particles when        chewing the chewing gum formulation, and    -   wherein the content of nitrosamines in the tobacco particles is        less than 5 mg TSNA (Tobacco specific nitrosamines)/kg tobacco,        such as less than 2, less than 1 or less than 0.5 mg TSNA/kg        tobacco.

Natural tobacco may contain carcinogenic nitrosamines, which have beenshown to be harmful to man, mainly due to their carcinogenic properties.Therefore, when tobacco particles with a comparatively low content ofnitrosamines are used in the chewing gum formulation, furtheradvantageous embodiments of the present invention are obtained.

In an embodiment of the invention a chewing gum formulation comprisestobacco particles and a gum base, wherein the gum base comprises one ormore hydrophobic gum base polymers, and wherein the tobacco particlesare made from tobacco leaves,

-   -   wherein the amount of tobacco particles is between 0.5 and 30%        by weight of the chewing gum formulation,    -   wherein nicotine is released from the tobacco particles when        chewing the chewing gum formulation, and    -   wherein the ratio by weight between gum base and tobacco        particles is between 50:1 and 1:2, preferably between 25:1 and        1:1, such as between 10:1 and 2:1, and wherein the chewing gum        formulation further comprises buffer.

The combination of tobacco particles and buffer in the chewing gumformulation has surprisingly shown synergistic effects with respect toboth release of nicotine from the chewing gum formulation and thebio-availability of the released nicotine through the mucous membrane ofthe user.

In an embodiment of the invention a chewing gum formulation comprisestobacco particles and a gum base, wherein the gum base comprises one ormore hydrophobic gum base polymers, and wherein the tobacco particlesare made from tobacco leaves,

-   -   wherein the amount of tobacco particles is between 0.5 and 30%        by weight of the chewing gum formulation,    -   wherein nicotine is released from the tobacco particles when        chewing the chewing gum formulation, and    -   wherein the tobacco fibres are retained in the gum base after a        chewing process.

To the surprise of the inventor nicotine was seen to be released fromthe tobacco particles in the chewing gum formulation while the tobaccofibres surprisingly were retained in the gum base of the chewing gumformulation after chewing the formulation. In this way, the weight ofthe individual tobacco particle may diminish during the chewing processdue to released substances, but a substantial part of the individualtobacco particle is retained in the gum base. In particular the tobaccofibre content of the tobacco particles may be retained in the chewinggum after a chewing process.

It has been found that the amount of gum base in the chewing guminfluences the retention of tobacco particles or the retention oftobacco fibre content of the tobacco particles in the chewing gumformulation. A higher gum base content gives rise to a better retentionwhich means that more tobacco fibres are retained in the chewing gumafter chewing according to the procedures outlined above. When the gumbase content of the chewing gum is lowered, the amount of retainedtobacco fibres is less than for a higher gum base content.

In an embodiment of the invention a chewing gum formulation comprisestobacco particles and a gum base, wherein the gum base comprises one ormore hydrophobic gum base polymers, and wherein the tobacco particlesare made from tobacco leaves,

-   -   wherein the amount of tobacco particles is between 0.5 and 30%        by weight of the chewing gum formulation,    -   wherein nicotine is released from the tobacco particles when        chewing the chewing gum formulation, and    -   wherein more than 0.5 mg nicotine, such as more than 0.8 mg or        more than 1.0 mg, is released from the chewing gum formulation        within the first 5 minutes from initiation of a chewing process.

It has surprisingly been found by the present inventor that if arelatively fast release of nicotine from the chewing gum formulation isto be obtained, according to the present invention, it is advantageousto use tobacco particles as the source of nicotine.

In an embodiment of the invention a chewing gum formulation comprisestobacco particles and a gum base, wherein the gum base comprises one ormore hydrophobic gum base polymers, and wherein the tobacco particlesare made from tobacco leaves,

-   -   wherein the amount of tobacco particles is between 0.5 and 30%        by weight of the chewing gum formulation,    -   wherein nicotine is released from the tobacco particles when        chewing the chewing gum formulation, and    -   wherein the tobacco particles have been mixed into the gum base.

By mixing tobacco particles with the hydrophobic gum base polymers priorto mixing with other chewing gum ingredients, a moderated release ofnicotine from the chewing gum formulation may be obtained. In thepresent context it was seen as a surprise by the inventors that it waspossible to mix the tobacco particles with the hydrophobic gum basepolymers. In particular it was not foreseen that it was possible to mixthe tobacco particles with the hydrophobic gum base polymers, whentobacco particles with a content of water were applied.

In an embodiment of the invention a chewing gum formulation comprisestobacco particles and a gum base, wherein the gum base comprises one ormore hydrophobic gum base polymers, and wherein the tobacco particlesare made from tobacco leaves,

-   -   wherein the amount of tobacco particles is between 0.5 and 30%        by weight of the chewing gum formulation,    -   wherein nicotine is released from the tobacco particles when        chewing the chewing gum formulation, and    -   wherein the tobacco leaves have been exposed to a heat steaming        process, thereby reducing the viable bacterial and fungal        numbers of the tobacco leaves by at least 80%, preferably at        least 90%, such as 99 or 99.9.

Reducing the vial bacterial and fungal numbers in the tobacco leaves maylengthen the shelf life of the chewing gum formulation according toembodiments of the present invention. It has surprisingly been found bythe present inventor that tobacco particles from tobacco leaves treatedwith different techniques to reduce the vial bacterial and fungalnumbers can be used according to a preferred embodiment of the presentinvention. According to this embodiment, such treatments do notnegatively affect the taste or release profile of the resulting chewinggum. In particular, a heat steaming process is advantageous.

In embodiments of the present invention, at least 50% by weight,preferably at least 75% by weight of the tobacco particles have a sizebetween 50 and 2000 μm, preferably between 100 and 1200 μm, such asbetween 300 and 750 μm.

In embodiments of the present invention, at least 50% by weight,preferably at least 75% by weight of the tobacco particles have a sizeabove 300 μm.

In embodiments of the present invention, at least 50% by weight,preferably at least 75% by weight of the tobacco particles have a sizebelow 700 μm.

In embodiments of the present invention, the tobacco particles have beenprepared such that less than 25% by weight, preferably less than 15% byweight of the tobacco particles is capable of passing through a 50 meshscreen.

In embodiments of the present invention, the tobacco particles have awater content ranging from 2 to 40% by weight, preferably 5 to 30% byweight, such as 10 to 20% by weight.

In embodiments of the present invention, the amount of moisturecontained in the tobacco particles is at least 2% by weight, such as atleast 4%, at least 6%, or at least 8% by weight of the tobacco particlescomprised in the chewing gum formulation.

In embodiments of the present invention, the amount of tobacco particlesin the chewing gum formulation is between 2-25%, such as 3-22%, 4-20% or5-15% by weight of the chewing gum formulation.

In embodiments of the present invention, the amount of tobacco particlesin the chewing gum formulation is at least 10 mg, such as at least 20mg, at least 30 mg or at least 40 mg.

In embodiments of the present invention, the amount of tobacco particlesin the chewing gum formulation is less than 400 mg, such as less than300 mg, less than 200 mg or less than 120 mg.

In embodiments of the present invention, the amount of nicotine in thetobacco particles is between 0.2-10%, preferably 0.4-8%, such as 0.6-6%or 0.8-4% by weight of the tobacco particles.

In embodiments of the present invention, the amount of nicotine from thetobacco particles in the chewing gum formulation is between 0.5 and 10mg, such as 1-8% or 1.5-6% by weight of the tobacco particles.

In embodiments of the present invention, the content of nitrosamines inthe tobacco particles is less than 0.1 μg nitrosamines/mg nicotine, suchas less than 0.05, less than 0.02 or less than 0.01 μg/mg nicotine.

In embodiments of the present invention, the content of nitrosamines inthe tobacco particles is less than 5 μg nitrosamines/g tobacco, such asless than 2, less than 1, less than 0.5, less than 0.2 or less than 0.1μg/g tobacco.

In embodiments of the present invention, the ratio by weight between gumbase and tobacco particles is between 50:1 and 1:2, preferably between25:1 and 1:1, such as between 10:1 and 2:1, and wherein the chewing gumformulation further comprises buffer.

In embodiments of the present invention, the amount of tobacco particlesis between 0.5-10% by weight of the chewing gum formulation, wherein theamount of gum base is between 20 and 90% by weight of the chewing gumformulation and wherein the chewing gum formulation comprises a buffer.

In embodiments of the present invention, the amount of buffer is in therange of 0.1% to 10%, preferably 0.5% to 5% by weight of the chewinggum.

In embodiments of the present invention, the chewing gum formulationcomprises buffer in an amount of less than 5%, such as less than 2%,less than 1%, or less than 0.5% by weight.

In embodiments of the present invention, the chewing gum formulation issubstantially free of buffer.

In embodiments of the present invention, the buffer is selected from thegroup consisting of sodium carbonate, sodium hydrogen carbonate,potassium carbonate, potassium hydrogen carbonate, dipotassiumphosphate, potassium citrate, or any combination thereof.

In embodiments of the present invention, the tobacco fibres are retainedin the gum base after a chewing process.

In embodiments of the present invention, at least 20% by weight, atleast 30% by weight, at least 40% by weight, 50% by weight, such as atleast 60%, such as at least 65%, such as at least 70%, such as at least75%, such as at least 80%, such as at least 85%, such as at least 90%,at least 95% or at least 99%, of the tobacco fibres are retained in thegum base about 10 minutes from initiation of a chewing process.

According to this embodiment of the invention, different mechanisms mayapply. First of all, the weight of the individual tobacco particle maydiminish during the chewing process due to released substances, but asubstantial part of the individual tobacco particle is retained in thegum base. In this respect the meaning of “diminish” would refer to aweight reduction of the individual particle. Secondly, some individualtobacco particles or tobacco fibres may be released during the chewingprocess. A combination may also occur.

In embodiments of the present invention, the amount of tobacco particlesin the chewing gum formulation is in the range of 20 mg to 400 mg, suchas 30 mg to 300 mg or 40 mg to 120 mg,

-   -   wherein, about 10 minutes from initiation of a chewing process,        more than 0.8 mg nicotine, such as more than 1.1 mg or more than        1.5 mg, is released from the chewing gum formulation, and    -   at the same time at least 20% by weight, at least 30% by weight,        at least 40% by weight, at least 50% by weight, at least 60% by        weight, such as at least 70%, at least 80%, at least 90%, at        least 95% or at least 99%, of the tobacco fibres are retained in        the gum base.

In embodiments of the present invention, more than 0.5 mg nicotine, suchas more than 0.8 mg or more than 1.0 mg, is released from the chewinggum formulation within the first 5 minutes from initiation of a chewingprocess.

In embodiments of the present invention, more than 0.8 mg nicotine, suchas more than 1.1 mg or more than 1.5 mg, is released from the chewinggum formulation within the first 10 minutes from initiation of a chewingprocess.

In embodiments of the present invention, more than 25% of the totalnicotine content in the chewing gum formulation, such as more than 40%or more than 50%, is released from the chewing gum formulation withinthe first 5 minutes from initiation of a chewing process.

In embodiments of the present invention, more than 40% of the totalnicotine content in the chewing gum formulation, such as more than 55%or more than 75%, is released from the chewing gum formulation withinthe first 10 minutes from initiation of a chewing process.

In embodiments of the present invention, the chewing process is carriedout in vitro on a chewing machine in accordance with EuropeanPharmacopeia 4 th. ed. 2.9.25, with a phosphate buffer with a pH of 7.4.

In embodiments of the present invention, the released amounts aremeasured when the chewing gum formulation is chewed in vitro inaccordance with European Pharmacopeia 4th. ed. 2.9.25 in a pH 7.4phosphate buffer.

In embodiments of the present invention, the tobacco particles have beenmixed into the gum base.

In embodiments of the present invention, the tobacco particles are mixedinto the chewing gum formulation along with the bulk portion of thechewing gum formulation.

In embodiments of the present invention, the gum base comprises

elastomer in the range of 5-40% by weight of the gum base,

natural resin in the range of 8-45% by weight of the gum base, and

synthetic resin in the range of 5-50% by weight of the gum base.

In embodiments of the present invention, the chewing gum formulationcomprises gum base in an amount of 15 to 95% by weight of the chewinggum formulation, preferably 20 to 90% by weight, such as 30 to 80% byweight, 40 to 75% by weight or 50 to 70% by weight.

In embodiments of the present invention, the chewing gum formulationcomprises gum base in an amount of 100 mg to 5000 mg, preferably 200 mgto 3000 mg, more preferably 300 mg to 2000 mg, such as 500 mg to 1500 mgor 800 mg to 1200 mg.

In embodiments of the present invention, the chewing gum formulationcomprises natural resins in an amount of 0.1 to 40%, preferably 1 to30%, such as 3 to 25% or 5 to 20%, by weight of the chewing gumformulation.

In embodiments of the present invention, the chewing gum formulationcomprises natural resins in an amount of at least 13% by weight of thechewing gum formulation.

In embodiments of the present invention, the chewing gum formulationcomprises synthetic resins in an amount of 0.1 to 40%, preferably 1 to30%, such as 3 to 25% or 5 to 20%, by weight of the chewing gumformulation.

In embodiments of the present invention, the chewing gum formulationcomprises elastomer in an amount of at least 2% by weight of the chewinggum formulation, preferably at least 4% by weight of the chewing gumformulation.

In embodiments of the present invention, the chewing gum formulationcomprises elastomer in an amount of less than 35% by weight of thechewing gum formulation, preferably less than about 25% by weight of thechewing gum formulation such as less than 20%, 15% or 10% by weight ofthe chewing gum formulation.

In embodiments of the present invention, the tobacco leaves have beenexposed to a heat steaming process, thereby reducing the viablebacterial and fungal numbers of the tobacco leaves by at least 80%,preferably at least 90%, such as 99 or 99.9.

In embodiments of the present invention, the tobacco leaves have beenexposed to a heat steaming process, thereby reducing the viablebacterial and fungal numbers in the tobacco leaves down below 10,000CFU/g (colony-forming units per gram), such as below 1,000 or below 100CFU/g.

In embodiments of the present invention, more than 15% of the totalflavour content in the chewing gum formulation, such as more than 25% ormore than 40%, is released from the chewing gum formulation within thefirst 5 minutes from initiation of a chewing process.

In embodiments of the present invention, more than 20% of the totalflavour content in the chewing gum formulation, such as more than 35%,more than 50% or more than 70%, is released from the chewing gumformulation within the first 10 minutes from initiation of a chewingprocess.

In embodiments of the present invention, the chewing gum formulationcomprises one or more flavoring agents selected from the groupconsisting of essential oils, essences, extracts, powders, acids,coconut, coffee, chocolate, vanilla, grape fruit, orange, lime, menthol,liquorice, caramel aroma, honey aroma, peanut, walnut, cashew, hazelnut,almonds, pineapple, strawberry, raspberry, apple, pear, peach, apricot,blackberry, cherry, pineapple, plum essence, clove oil, bay oil, anise,thyme, cedar leaf oil, nutmeg, cinnamon, peppermint, wintergreen,spearmint, eucalyptus, mint, or any combination thereof.

In embodiments of the present invention, the chewing gum formulationcomprises at least one of brightleaf, burley-leaf, oriental-leaftobacco, Dark air cured Burley, Flue cured Virginia, and dark firedKentucky.

In embodiments of the present invention, the chewing gum formulationcomprises humectants, such as propylene glycol or glycerol.

In embodiments of the present invention, the chewing gum formulationcomprises enhancers such as cocoa solids, licorice, tobacco extracts,and sugars.

In embodiments of the present invention, the chewing gum formulation isprovided with a coating.

In embodiments of the present invention, the chewing gum formulation hasa weight in the range of 0.1 to 10 grams, preferably in the range of 0.5to 4 grams.

In embodiments of the present invention, the chewing gum comprisesfiller in an amount of 0.1 to 50% by weight of the chewing gum.

According to an advantageous embodiment of the invention, the chewingmay comprise filler. The filler may advantageously be suitable forfacilitating the water uptake of the fibres of the tobacco particles andit may also be suitable for facilitating the release of the ingredientsof the tobacco particles when a user chews the chewing gum. Inparticular, it is noted that the filler may advantageously support thefunctionality of the fibres contained in the tobacco powder.

In embodiments of the present invention, the chewing gum comprisesfiller in an amount of 0.1 to 50% by weight of the chewing gum, whereinthe filler is hydrophobic and wherein at least 90% of the filler iscontained in the chewing gum throughout the chewing of a user during achewing period of at least 10 minutes.

According to an advantageous embodiment of the invention the chewing gumcomprises filler in an amount of 0.1 to 50% by weight of the chewinggum, wherein the filler is hydrophobic and wherein at least 90% of thefiller is contained in the chewing gum throughout the chewing of a userduring a chewing period of at least 10 minutes.

The chewing of the chewing gum throughout the period of at least 10minutes may be set forth by the procedure set forth in the Ph. Eur.6^(th) ed. 2.9.25, at pH=7.4, a chewing rate of 60 chew per minute, andwith the temperature of the medium at 37° C., whereas the measurement ofthe retained filler may be established by measuring on the remainingchewing gum or measuring of the released components, whichever method ismost appropriate.

In embodiments of the present invention, the chewing gum comprisesfiller in an amount of 0.1 to 50% by weight of the chewing gum andwherein the filler comprises magnesium and calcium carbonate, sodiumsulphate, ground limestone, silicate compounds such as magnesium andaluminum silicate, kaolin and clay, aluminum oxide, silicium oxide,talc, titanium oxide, mono-, di- and tri-calcium phosphates, cellulosepolymers, such as wood, and combinations thereof.

In embodiments of the present invention, the chewing gum is a compressedchewing gum tablet.

In embodiments of the present invention, the compressed chewing gumtablet is a multi-layer tablet.

In embodiments of the present invention, the chewing gum has the form ofa slab or stick.

In an embodiment of the invention, the tobacco particles comprisestobacco fibres and at least 20% of the tobacco fibres are retained inthe gum base after a 10 minute chewing process.

In embodiments of the present invention, at least 30%, preferably atleast 40% and even more preferred at least 50% of the tobacco fibres areretained in the chewing gum after the chewing gum has been chewed invitro in accordance with European Pharmacopeia 4th. ed. 2.9.25 in a pH7.4 phosphate buffer for 10 minutes.

In embodiments of the present invention, at least 60% of the tobaccofibres are retained in the chewing gum after the chewing gum has beenchewed in vitro in accordance with European Pharmacopeia 4th. ed. 2.9.25in a pH 7.4 phosphate buffer for 10 minutes.

In embodiments of the present invention, at least 70% of the tobaccofibres are retained in the chewing gum after the chewing gum has beenchewed in vitro in accordance with European Pharmacopeia 4th. ed. 2.9.25in a pH 7.4 phosphate buffer for 10 minutes.

In embodiments of the present invention, at least 80% of the tobaccofibres are retained in the chewing gum after the chewing gum has beenchewed in vitro in accordance with European Pharmacopeia 4th. ed. 2.9.25in a pH 7.4 phosphate buffer for about 10 minutes.

In embodiments of the present invention, at least 85% of the tobaccofibres are retained in the chewing gum after the chewing gum has beenchewed in vitro in accordance with European Pharmacopeia 4th. ed. 2.9.25in a pH 7.4 phosphate buffer for about 10 minutes.

In an embodiment of the invention the relative release of nicotine fromthe tobacco powder in the chewing gum formulation is greater than therelative release of tobacco fibres from the chewing gum formulation whenthe chewing gum formulation is chewed for 10 minutes.

Moreover, the invention relates to a method of preparing a chewing gumformulation comprising tobacco particles and gum base, the methodcomprising the steps of:

-   -   preparing a gum base and    -   blending the gum base with tobacco particles, an effective        amount of buffer and other chewing gum ingredients at a        temperature below 60° C.

Moreover, the invention relates to a method of preparing a chewing gumformulation comprising tobacco particles and gum base,

-   -   wherein the tobacco particles is mixed with other chewing gum        ingredients including the hydrophobic gum base constituents in        the chewing gum formulation and an effective amount of buffer,        the mixing being performed at a temperature below 60° C.

DETAILED DESCRIPTION OF THE INVENTION

By the terms “gum base” and “gum base matrix” we mean the mainly waterinsoluble and hydrophobic gum base ingredients that are mixed togetherbefore the bulk portion of the chewing gum formulation is added.

The term “bulk portion” intends to mean the mainly water soluble chewingand hydrophilic gum ingredients that are mixed into the gum base matrixafter it has been mixed.

The term “weight of the chewing gum formulation” or similar wordingmeaning the same is defined in the present context as weight of thechewing gum formulation, without including the weight of an outercoating, such as a hard coating, soft coating, and the like.

By the phrase “chewing gum” is meant any chewing gum such as extrudedchewing gum, centre-filled chewing gum, toffee-imitating chewing gum,compressed chewing gum, slabs or sticks.

By the phrase “texture” is meant a qualitative measure of thevisco-elastic properties of the chewing gum and of the overallmouth-feel experienced by the user during the chewing process. Thus theterm “texture” encompasses measurable quantities such as hardness andelasticity as well as more subjective parameters related to thechew-feel experienced by a user.

By the phrase “retained” is meant that e.g. fibres of tobacco powder arecontained within the gum base of the chewing gum formulation after ithas been chewed.

The phrase “hydrophobic” is used to describe the ability of a substanceto dissolve in or blend with apolar substances such as e.g. oils.

The phrase hydrophilic is used to describe the ability of a substance todissolve in or blend with polar substances, such as e.g. water.

By the phrase “tobacco particles” is meant small parts made from tobaccoleaves by conventional techniques.

According to embodiments of the invention, the gum base matrix mayconstitute 50 to 80% by weight of the chewing gum formulation. Theamount of gum base may in some embodiments constitute 60 to 70% byweight of the chewing gum formulation. According to other embodiments ofthe invention, the gum base matrix may constitute 20 to 50% by weight ofthe chewing gum formulation. The amount of gum base may in someembodiments constitute 30 to 40% by weight of the chewing gumformulation.

In some embodiments of the invention, a buffer is added, the bufferbeing selected from the group consisting of a tris buffers, amino acidbuffers, carbonate, including monocarbonate, bicarbonate orsesquicarbonate, glycerinate, phosphate, glycerophosphate, acetate,glyconate or citrate of an alkali metal, such as potassium and sodium,e.g. trisodium and tripotassium citrate, or ammonium, and mixturesthereof.

When buffer is used, a preferred buffer is sodium bicarbonate. In someembodiments buffer is not part of the chewing gum formulation. In someother embodiments, buffer is part of the chewing gum formulation.

In some embodiments of the invention, the amount of buffer is 0.5 to 10%by weight of the chewing gum formulation.

In some embodiments of the invention the buffer is selected from thegroup consisting of a carbonate, including monocarbonate, bicarbonate orsesquicarbonate, glycerinate, phosphate, glycerophosphate, acetate,glyconate or citrate of an alkali metal, such as potassium and sodium,e.g. trisodium and tripotassium citrate, or ammonium, tris buffer, aminoacids, and mixtures thereof.

In some embodiments of the invention the buffer is selected from thegroup consisting of Acetic acid, Adipic acid, Citric acid, Fumaric acid,Glucono-δ-lactone, Gluconic acid, Lactic acid, Malic acid, Maleic acid,Tartaric acid, Succinic acid, Propionic acid, Ascorbic acid, Phosphoricacid, Sodium orthophosphate, Potassium orthophosphate, Calciumorthophosphate, Sodium diphosphate, Potassium diphosphate, Calciumdiphosphate, Pentasodium triphosphate, Pentapotassium triphosphate,Sodium polyphosphate, Potassium polyphosphate, Carbonic acid, Sodiumcarbonate, Sodium bicarbonate, Potassium carbonate, Calcium carbonate,Magnesium carbonate, Magnesium oxide, or any combination thereof.

The buffer may to some extent be microencapsulated or otherwise coatedas granules with polymers and/or lipids being less soluble in salivathan is the one or more buffering agents. Such microencapsulationcontrols the dissolution rate whereby is extended the time frame of thebuffering effect.

However, in a presently preferred embodiment an alkaline buffer ispreferred, such as sodium carbonate.

According to the invention the presence of buffer allows in synergy withtobacco particles in the chewing gum formulation to adjust the releaseof nicotine from the tobacco particles and the bioavailability of thereleased nicotine in the oral cavity.

According to the invention a preferred amount of gum base matrix in thefinal chewing gum is above 30 percent by weight of the chewing gum core,such as above 35 percent by weight of the chewing gum core, such asabove 40 percent by weight of the chewing gum core, such as above 45percent by weight of the chewing gum core, such as about 40 percent byweight of the chewing gum core, such as about 47 percent by weight ofthe chewing gum core.

The formulation of gum base formulations can vary substantiallydepending on the particular product to be prepared and on the desiredmasticatory and other sensory characteristics of the final product.However, typical ranges (% by weight) of the above gum base componentsare: 5 to 80% by weight elastomeric compounds, 5 to 80% by weightelastomer plasticizers, 0 to 40% by weight of waxes, 5 to 35% by weightsoftener, 0 to 50% by weight filler, and 0 to 5% by weight ofmiscellaneous ingredients such as antioxidants, colourants, etc. The gumbase may comprise about 5 to about 95 percent, by weight, of the chewinggum, more commonly the gum base comprises 10 to about 60 percent, byweight, of the gum.

Elastomers provide the rubbery, cohesive nature to the gum, which variesdepending on this ingredient's chemical structure and how it may becompounded with other ingredients. Elastomers suitable for use in thegum base and gum of the present invention may include natural orsynthetic types.

Elastomer plasticizers vary the firmness of the gum base. Theirspecificity on elastomer inter-molecular chain breaking (plasticizing)along with their varying softening points cause varying degrees offinished gum firmness and compatibility when used in base. This may beimportant when one wants to provide more elastomeric chain exposure tothe alkane chains of the waxes.

The elastomers (rubbers) employed in the gum base may vary dependingupon various factors such as the type of gum base desired, the textureof gum formulation desired and the other components used in theformulation to make the final chewing gum product. The elastomer may beany water-insoluble polymer known in the art, and includes those gumpolymers utilized for chewing gums and bubble gums. Illustrativeexamples of suitable polymers in gum bases include both natural andsynthetic elastomers. For example, those polymers which are suitable ingum base formulations include, without limitation, natural substances(of vegetable origin) such as chicle gum, natural rubber, crown gum,nispero, rosidinha, jelutong, perillo, niger gutta, tunu, balata,guttapercha, lechi capsi, sorva, gutta kay, and the like, and mixturesthereof. Examples of synthetic elastomers include, without limitation,styrene-butadiene copolymers (SBR), polyisobutylene,isobutylene-isoprene copolymers, polyethylene, polyvinyl acetate and thelike, and mixtures thereof.

In some embodiments of the present invention tobacco powder is added tothe gum base together with other gum base ingredients.

Natural resins may be used according to the invention and may be naturalrosin esters, often referred to as ester gums including as examplesglycerol esters of partially hydrogenated rosins, glycerol esters ofpolymerised rosins, glycerol esters of partially dimerized rosins,glycerol esters of tally oil rosins, pentaerythritol esters of partiallyhydrogenated rosins, methyl esters of rosins, partially hydrogenatedmethyl esters of rosins, pentaerythritol esters of rosins, syntheticresins such as terpene resins derived from alpha-pinene, beta-pinene,and/or d-limonene, and natural terpene resins.

In an embodiment of the invention, the resin comprises terpene resins,e.g. derived from alpha-pinene, beta-pinene, and/or d-limonene, naturalterpene resins, glycerol esters of gum rosins, tall oil rosins, woodrosins or other derivatives thereof such as glycerol esters of partiallyhydrogenated rosins, glycerol esters of polymerized rosins, glycerolesters of partially dimerised rosins, pentaerythritol esters ofpartially hydrogenated rosins, methyl esters of rosins, partiallyhydrogenated methyl esters of rosins or pentaerythritol esters of rosinsand combinations thereof.

In an embodiment of the invention, said chewing gum ingredients areselected from the group consisting of bulk sweeteners, flavors,dry-binders, tabletting aids, anti-caking agents, emulsifiers,antioxidants, enhancers, absorption enhancers, buffers, high intensitysweeteners, softeners, colors, or any combination thereof.

The tobacco particles may in some embodiments of the invention be addedto the chewing gum as a part of the bulk portion together with the otherchewing gum ingredients.

In an embodiment of the invention, the chewing gum formulation comprisessweeteners, such as bulk sweeteners, sugar sweeteners, sugar substitutesweeteners, artificial sweeteners, high-intensity sweeteners, or anycombination thereof.

Suitable bulk sweeteners include both sugar and non-sugar sweeteningcomponents. Bulk sweeteners typically constitute from about 5 to about95% by weight of the chewing gum, more typically about 20 to about 80%by weight such as 30 to 70% or 30 to 60% by weight of the gum.

Useful sugar sweeteners are saccharide-containing components commonlyknown in the chewing gum art including, but not limited to, sucrose,dextrose, maltose, dextrins, trehalose, D-tagatose, dried invert sugar,fructose, levulose, galactose, corn syrup solids, and the like, alone orin combination.

Sorbitol can be used as a non-sugar sweetener. Other useful non-sugarsweeteners include, but are not limited to, other sugar alcohols such asmannitol, xylitol, hydrogenated starch hydrolysates, maltitol, isomalt,erythritol, lactitol and the like, alone or in combination.

High intensity artificial sweetening agents can also be used alone or incombination with the above sweeteners. Preferred high intensitysweeteners include, but are not limited to sucralose, aspartame, saltsof acesulfame, alitame, saccharin and its salts, cyclamic acid and itssalts, glycyrrhizin, dihydrochalcones, thaumatin, monellin, steriosideand the like, alone or in combination. In order to provide longerlasting sweetness and flavor perception, it may be desirable toencapsulate or otherwise control the release of at least a portion ofthe artificial sweeteners. Techniques such as wet granulation, waxgranulation, spray drying, spray chilling, fluid bed coating,conservation, encapsulation in yeast cells and fiber extrusion may beused to achieve desired release characteristics. Encapsulation ofsweetening agents can also be provided using another chewing gumcomponent such as a resinous compound.

Usage level of the artificial sweetener will vary considerably and willdepend on factors such as potency of the sweetener, rate of release,desired sweetness of the product, level and type of flavor used and costconsiderations. Thus, the active level of artificial sweetener may varyfrom about 0.001 to about 8% by weight (preferably from about 0.02 toabout 8% by weight). When carriers used for encapsulation are included,the usage level of the encapsulated sweetener will be proportionatelyhigher. Combinations of sugar and/or non-sugar sweeteners may be used inthe chewing gum formulation.

A chewing gum base formulation may, if desired, include one or morefillers/texturisers including as examples, magnesium and calciumcarbonate, sodium sulphate, ground limestone, silicate compounds such asmagnesium and aluminum silicate, kaolin and clay, aluminum oxide,silicium oxide, talc, titanium oxide, mono-, di- and tri-calciumphosphates, cellulose polymers, such as wood, and combinations thereof.

A number of chewing gum components well known within the art may beapplied within the scope of the present invention. Such componentscomprise but are not limited to waxes, fats, softeners, fillers,flavors, anti-oxidants, emulsifiers, colouring agents, binding agentsand acidulants

In an embodiment of the invention, the chewing gum formulation isprovided with an outer coating.

In an embodiment of the invention, said outer coating is selected fromthe group consisting of hard coating, soft coating and ediblefilm-coating or any combination thereof.

The following non-limiting examples illustrate different variations ofthe present invention. The examples are meant for indicating theinventive concept; hence the mentioned examples should not be understoodas exhaustive for the present invention.

EXAMPLES Example 1 Preparation of Gum Base without Tobacco Particles

The composition of a gum base is presented in Table 1.

TABLE 1 Gum base composition. Amounts are given in wt-% of the gum base.GB std. Elastomer 16.0 Resins 44.5 Filler 15.0 Plasticizers 24.4Antioxidant 0.1 GB = Gum Base.

The preparation of gum base is carried out by first adding ahigh-molecular weight elastomer, synthetic resin and filler to a heated(about 120° C.) and running z-blade mixer. After about twenty minutes ofmixing, natural resin is added to the running mixer and mixing iscontinued for about five minutes followed by addition of further naturalresin. After about five minutes of continued mixing, some plasticizerand further elastomer are added to the running mixer, and mixing iscontinued for about five minutes before addition of further plasticizerand antioxidant to the running mixer. Mixing is continued for about halfan hour to one hour, and the final gum base mass is emptied from themixer into coated or lined pans, extruded or cast into any desirableshape. Those skilled in the art will recognize that many variations ofthe above-described procedure may be followed.

Example 2 Preparation of Chewing Gum

In the present example, the gum base standard from example 1 GB std. wasmade into chewing gum CG std. with the composition as described in Table2.

TABLE 2 Amounts are given in % by weight of the chewing gum formulation.CG std. GB std. 42 Tobacco particles 5 Bulk Sweetener Sorbitol 50.3Tobacco flavour 2 Intense sweeteners 0.7 CG = Chewing Gum

A conventional mechanical mixing procedure is used. The gum base isadded to a mixing kettle provided with mixing means like e.g.horizontally placed Z-shaped arms. The kettle had been preheated to atemperature of up to approximately 50° C., and the other ingredients areadded according to a specified time schedule. Obviously, the amount ofingredients used may be varied within the scope of the presentinvention.

The chewing gum formulation may optionally be coated by means of hardcoating. The coating may e.g. be applied according to conventionalcoating methods. The pieces evaluated are without coating.

Example 3 Preparation of Chewing Gum with Tobacco Particles, Size/Amount

Chewing gums comprising varying sizes and amounts of tobacco particleswere made according to various embodiments of the present invention.

The chewing gum of example 2 was used with tobacco particles withtobacco amount and size as indicated in Table 3 replacing thecorresponding amount of bulk sweetener. The resulting chewing gums arein Table 3 named for later reference.

TABLE 3 Avg. size is the average maximum dimension of the tobaccoparticles and the amount of tobacco is given in % by weight of thechewing gum Avg. size (μm) Tobacco (wt-%) 40 250 500 750 2500 1 CG01CG06 CG11 CG16 CG21 5 CG02 CG07 CG12 CG17 CG22 10 CG03 CG08 CG13 CG18CG23 20 CG04 CG09 CG14 CG19 CG24 30 CG05 CG10 CG15 CG20 CG25

The chewing gum with lower tobacco content (1-5 wt-%) had a mild tasteof tobacco while with higher tobacco content (10-30 wt-%) had a distinctand pleasant tobacco taste.

Example 4 Preparation of Chewing Gum with Tobacco Particles, NicotineContent

Chewing gums comprising tobacco particles with varying nicotine contentwere made according to various embodiments of the present invention. Thevarying nicotine content may be obtained by using either low- and/orhigh-nicotine containing types of tobacco in any combination. Hereby adesired nicotine content in the tobacco particles to be used may beobtained as seen in Table 4 below.

The chewing gum of example 2 was used with different types of tobaccoparticles replacing the corresponding amount of bulk sweetener, whichcontained amounts of nicotine as indicated in Table 4. The resultingchewing gums are in Table 4 named for later reference.

TABLE 4 The amount of tobacco is given in % by weight of the chewing gumand the amount of nicotine is given in % by weight of the tobacco.Tobacco (wt-%) Nicotine (wt-%) 1 5 10 20 30 0.3 CG26 CG31 CG36 CG41 CG460.7 CG27 CG32 CG37 CG42 CG47 1.7 CG28 CG33 CG38 CG43 CG48 3.4 CG29 CG34CG39 CG44 CG49 8.4 CG30 CG35 CG40 CG45 CG50Surprisingly, the chewing gums with highest nicotine content still had apleasant taste and texture.

Example 5 Preparation of Chewing Gum with Tobacco Particles, MoistureContent

Chewing gums comprising tobacco particles with varying moisture contentwere made according to various embodiments of the present invention. Thevarying moisture content may be obtained by drying or adding extra waterto any type of tobacco before adding it to the chewing gum. Hereby adesired moisture content in the tobacco particles to be used may beobtained as seen in Table 5 below.

The chewing gum of example 2 was used with tobacco particles, which hada moisture content as indicated in Table 5, replacing the correspondingamount of bulk sweetener. The resulting chewing gums are in Table 5named for later reference.

TABLE 5 The amount of tobacco is given in % by weight of the chewing gumand the moisture content is given in % by weight of the tobacco. Tobacco(wt-%) Moisture (wt-%) 1 5 10 20 30 2 CG51 CG56 CG61 CG66 CG71 5 CG52CG57 CG62 CG67 CG72 11 CG53 CG58 CG63 CG68 CG73 18 CG54 CG59 CG64 CG69CG74 26 CG55 CG60 CG65 CG70 CG75Surprisingly, the moisture content of the tobacco particles may bevaried without compromising taste and texture of the chewing gum.

Example 6 Preparation of Chewing Gum with Tobacco Particles, Buffer

Chewing gums comprising tobacco particles with varying sizes werecombined with various amounts of buffer according to various embodimentsof the present invention.

The chewing gum of example 2 was used with buffer in amounts asindicated in Table 6 and tobacco particles in an amount of 5% of thechewing gum replacing the corresponding amount of bulk sweetener. Thebuffer used was a 50/50 by weight of NaHCO₃ and Na₂CO₃. The resultingchewing gums are in Table 5 named for later reference.

TABLE 6 The nicotine content is given in % by weight of the tobaccoparticles and the buffer content is given in % by weight of the chewinggum Nicotine (wt-%) Buffer (wt-%) 0.7 2.4 4.3 0 CG76 CG81 CG86 0.5 CG77CG82 CG87 3 CG78 CG83 CG88 6 CG79 CG84 CG89 8 CG80 CG85 CG90

Example 7 Preparation of Chewing Gum with Tobacco Particles,GB-Ingredients

Chewing gums with tobacco particles in combination with varying gum baseingredients were made according to various embodiments of the presentinvention. The resulting gum bases were made into chewing gums inaccordance with the description in example 2. The resulting chewing gumsare in Table 7 named for later reference.

TABLE 7 The content of the individual ingredients are given in % byweight of the gum base. CG91 CG92 CG93 CG94 CG95 CG96 CG97 Elastomer16.0 17.5 10.0 16.0 13.0 19.0 15.0 Resins 44.5 48.0 49.7 40 37.5 26.532.5 Filler 1.0 2.5 2.6 6.5 11.0 16.0 4.0 Plasticizers 24.4 18 23.6 23.524.4 24.4 34.4 Antioxidant 0.1 0.05 0.1 0.0 0.1 0.1 0.1 Tobacco 14 14 1414 14 14 14

Example 8 In Vitro Release of Nicotine

The release rate of nicotine from CG14 in Example 3 with tobaccoparticles with app. 11% moisture content and 2-3% nicotine, was measuredaccording to the procedure set forth in the Ph. Eur. 6^(th) ed. 2.9.25,at pH=7.4, a chewing rate of 60 chew per minute, and with thetemperature of the medium at 37° C. With the same setting, the releaserate from three prior art pieces, PA1, PA3, PA4, of nicotine gum wasmeasured for comparison. The release rate can be seen in Table 8.

TABLE 8 the time given is from initiation of a chewing process asdescribed and the values given are % by weight of the total content ofnicotine in the products CG14 PA4 CG98 PA1 PA3 Time (Wt-%) (Wt-%) (Wt-%)(Wt-%) (Wt-%)  5 min 61 51 83 45 15 10 min 85 72 91 66 36 20 min 89 9295 83 56 30 min 90 95 97 90 70

The results clearly show a significantly faster release of nicotine fromthe tobacco chewing gum formulation according to an embodiment of thepresent invention as compared to conventional nicotine gum.

A number of further measurements were carried out with other chewinggums with varying contents of tobacco particles, elastomers, resins andbuffer were tested and showed in general an improved faster release ofnicotine as compared to conventional chewing gum.

It is noted that the CG14 and PA4 are directly comparable and both havethe same gum base composition and gum base content.

The gum base content and gum base composition is also the same for CG98and PA1 but differs from CG14 and PA4.

The chewing gum composition of PA3 is unknown but refers to a Nicorettenicotine chewing gum where nicotine is contained in the form of anicotine polacrilex resin (NPR), as is also the case for PA1 and PA4.

Example 9 In Vitro Release, Retention of Fibres of Tobacco Particles

The retention of the fibres of tobacco particles in the gum base uponchewing chewing gum was investigated by carrying out the procedure setforth in the Ph. Eur. 6^(th) ed. 2.9.25, at pH=7.4, a chewing rate of 60chew per minute, and with the temperature of the medium at 37° C.

The chewing time was 10 minutes.

The buffer from the chewing process was collected and filtered throughweighed filter paper (pore size 5-10 micrometer) and dried in an oven at50° C. until dry.

CG99 was a extruded chewing gum pellet comprising tobacco powdercorresponding to a nicotine content of 2% by weight of the pellet.

CG100 was a 2 layer compressed chewing gum tablet with tobacco powder inone layer corresponding to a nicotine content of 2% by weight of thetablet.

CG102 was an extruded chewing gum pellet comprising no tobacco powderand thus represents a blind.

TABLE 9 Release of tobacco fibers from chewing gum tablets and chewinggum pellets compared to a blind. Initial Filter Dried filter FibersFibers retained on Release of fibers amount tobacco paper paper withretained on the filter corrected (>10 μm) from Product powder mg Mgfibers mg the filter mg for blind mg chewing gum %) CG99 127 547 558.411.4 17.8 35 CG100 97.6 546.7 571.5 24.8 31.2 80 CG102 0 537.6 531.2−6.4 0 0

The chewing gums CG 99 and CG 100 were made from the below gum bases GB99 and GB 100 and the applied tobacco powder was added to the chewinggum composition.

GB99 GB100 Elastomer 14 20 Resins 40 37 Filler 21 19 Plasticizers 24.923.95 Antioxidant 0.1 0.05

The chewing gum compositions were:

CG99 CG100 GB99 40 GB100 42 Tobacco particles 12.7 6.1 Bulk Sweetener 3846 Flavour 2.5 2.35 Intense sweeteners 1.8 1.25 Buffer and softener 5.02.3Table 9 shows that about 35% of tobacco fibers are released in anextruded chewing gum pellet (CG 99),

It should be noted that the retention of tobacco particles refer to thefibre content as initial content of e.g. humidity or other compounds, inparticular hydrophilic compounds in the tobacco powder will at least tosome extend be released during chewing. In the present context,measurements have shown that the applied tobacco particles containsabout 60% hydrophilic components and about 40% fibres.

It should also be noted that CG100 shows a relatively high release oftobacco fibers. In this context, it should be noted that compressedchewing gum release nicotine even faster than CG99 which is aconventional mixed chewing gum. Hence, the relative release of fibres isalso less than the release of nicotine in CG100.

It has been shown that fibres of tobacco particles showed retention inthe gum base and only moderate transferring of the tobacco fibre contentof the tobacco particles into the saliva occurs when using a mixedchewing gum even in spite of the fact that the nicotine releases faster.

Other visual tests performed on extruded or batch mixed chewing gumsindicated that fibre content of the tobacco powder is retained to alarge degree in spite of the fact that the chewing gum tested all showedincreased release of nicotine compared to conventional nicotine chewinggum, where the nicotine is contained in e.g. NPR. In other words, therewere clear indications that the chewing gums according to the provisionsof the invention were able to retain substantial amounts of the tobaccofibres and release the nicotine contained in the tobacco powder.

Example 10 Preparation of Gum Base with Tobacco Particles

The composition of a further gum base is presented in Table 10.

TABLE 10 Gum base composition. Amounts are given in wt-% of the gumbase. GB std. Elastomer 16.0 Resins 44.5 Filler 5.0 Tobacco particles10.0 Plasticizers 24.4 Antioxidant 0.1 GB = Gum Base.

As compared to the gum base of example 1, tobacco particles are includedin the gum base. This gum base is further made into a chewing gum asdescribed in example 2, only without the tobacco particles. However,obviously a combination of tobacco particles inside and outside a gumbase may be used as well within the scope of the present invention.

1. Chewing gum formulation comprising tobacco particles and a gum base,wherein the gum base comprises one or more hydrophobic gum basepolymers, and wherein the tobacco particles are made from tobaccoleaves, wherein the amount of tobacco particles is between 0.5 and 30%by weight of the chewing gum formulation, wherein nicotine is releasedfrom the tobacco particles when chewing the chewing gum formulation.2-75. (canceled)